Bristol Myers Squibb announced the Phase 2 TRANSCEND FL trial evaluating Breyanzi^® (lisocabtagene maraleucel) in adult patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma met its primary endpoint in the marginal zone lymphoma (MZL) cohort. Results showed Breyanzi demonstrated a statistically significant and clinically meaningful overall response rate (ORR) in these patients.

The study also met the key secondary endpoint of complete response rate (CRR). In the topline analysis, Breyanzi continued to demonstrate durable responses and a consistent safety profile with no new safety signals observed. This study marks the fifth cancer type in which Breyanzi has demonstrated clinically meaningful benefit, representing the broadest array of B-cell malignancies of any CD19-directed CAR T cell therapy and furthering evidence of Breyanzi’s best-in-class and best-in-disease profile.

“Marginal zone lymphoma is a slow-growing cancer that, for many, has a favorable prognosis. But for those patients who relapse or become refractory, the disease can be quite aggressive, and there is a need for new effective and tolerable treatment options to address this unmet critical need,” said Rosanna Ricafort, vice president, head of Late Development Program Leadership, Hematology and Cell Therapy, Bristol Myers Squibb. “We are pleased that the TRANSCEND FL study supports the potential of Breyanzi in marginal zone lymphoma and look forward to presenting detailed results from the study at an upcoming medical meeting.”

Bristol Myers Squibb thanks the patients and investigators who are participating in the TRANSCEND FL clinical trial.